Intra-arterial Chemotherapy for Spinal Metastases

Completed · Phase 1

Conditions studied: Spinal Diseases, Spinal Metastases, Spinal Tumors

In brief

Metastatic malignant tumors comprise the vast majority of spinal tumors in adults. The most devastating complication of spinal metastatic disease (SMD) is invasion of the spinal canal and compression of the spinal cord or the nerve roots of the cauda equina, resulting in a clinical entity known as cord compression that manifests with progressive loss of motor function and sensation in the legs, as well as bladder and bowel incontinence. The treatment of spinal metastases is mostly palliative with the goals of improving or maintaining neurologic function, achieving local tumor control, and spinal stability. Most patients with spinal metastatic disease are currently treated effectively with radiation therapy and/or surgery with good results. There are however certain limitations in the current treatment of SMD. Radiation therapy has two important limitations: 1) if the targeted SMD is in close proximity the spinal cord, delivery of high radiation doses is contraindicated as it may cause radiation-induced damage to the spinal cord (myelopathy, and 2) there is limit on the cumulative amount of radiation dose, which means that recurrent tumors may not be amenable to repeat radiation therapy. As far spinal surgery is concerned, the main limitation is that some patients are not fit for surgery because of medical co-morbidities. This phase I clinical research trial will test the hypothesis that a new minimally invasive treatment called spinal intra-arterial chemotherapy (SIAC) can be safely applied in patients with SMD.

Key facts

Study ID

NCT01637766

Run by

Weill Medical College of Cornell University

People needed

12

Starts

2012-04-01

Expected to finish

2018-12-01

Last updated by the study team

2020-08-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with metastatic diseases to the spine causing cord compression grades 1, and 2 who are not candidates for the standard treatment of radiation therapy or surgery.
• Patients older than 18 years old.
• Patients able to give informed consent.

You may not qualify if…

• MRI findings of grade 3 epidural cord compression.
• Rapidly worsening neurological symptoms.
• The vascular supply to the spinal cord (anterior and/or posterior spinal arteries) originates from the same segmental arteries (intercostal or lumbar arteries) supplying the tumor.
• Life expectancy less than 3 months.
• Pregnant or lactating patients.
• Female patients with inadequate contraception.
• History of severe allergy to contrast media.
• Renal insufficiency (Creatinine >1.5mg/dL)
• WBC < 3000 cells/ mm3
• Platelets < 75000 cells/ mm3

Where it is running

• Weill Cornell Medical College Department of Neurological Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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